Mediar Therapeutics Announces First Cohorts Dosed in Phase 1 Clinical Trial of MTX-439 for Fibrosis Associated with Chronic Kidney Disease (CKD) and Additions to Clinical Advisory Board

First-in-class antibody targeting SMOC2 is the third novel anti-fibrotic program to enter the clinic from Mediar's pipeline

Phase 1 study will evaluate safety, tolerability, and pharmacokinetics of novel SMOC2-targeting antibody in healthy volunteers and adults with diabetic kidney disease (DKD)

Addition of world-renowned CKD experts to the clinical advisory board (CAB) to help advise Phase 2a development in DKD patients

Phase 2a programs for systemic sclerosis (SSc) and idiopathic pulmonary fibrosis (IPF) continue global enrollment

BOSTON, June 23, 2026 /PRNewswire/ -- Mediar Therapeutics, Inc., a clinical-stage biotechnology company pioneering first-in-class therapies to halt and reverse fibrosis, today announced that the first cohorts have been dosed in its Phase 1 clinical trial of MTX-439, a first-in-class anti-SMOC2 antibody treatment for fibrosis associated with chronic kidney disease (CKD).

"Initiating this clinical study of MTX-439 is an exciting milestone for Mediar that underscores our ongoing commitment to developing first-in-class fibrosis therapies," said Jeff Bornstein, MD, Chief Medical Officer, Mediar Therapeutics. "Advanced chronic renal disease and associated fibrosis has been increasing worldwide, impacting over 10% of the world's population. This represents a significant unmet need. We look forward to advancing MTX-439 through clinical development as we work to deliver better outcomes for these patients."

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, and pharmacokinetics of MTX-439 in healthy volunteers and adults with DKD. Diabetes is a leading risk factor for CKD, a condition for which there are currently no curative treatments. MTX-439 is a first-in-class monoclonal antibody inhibitor of SMOC2 designed to address renal fibrosis through targeted myofibroblast deactivation.

Concurrent with the advancement of MTX-439 into clinical development, Mediar has expanded its clinical advisory board (CAB) to include leading global experts in chronic kidney disease. Newly appointed members include:

• Joseph Bonventre, MD, PhD, Harvard Medical School
• Matthias Kretzler, MD, PhD, University of Michigan
• David Cherney, MD, PhD, FRCP University of Toronto
• Jonathan Barratt, MD, PhD, FRCP University of Leicester

"Fibrosis is a critical common pathway of CKD, leading to impaired kidney function and irreversible damage," said Dr. Joseph Bonventre, MD, PhD, Chief Emeritus, Division of Renal Medicine at Brigham and Women's Hospital and Samuel A. Levine Distinguished Professor at Harvard Medical School. "Understanding the biological mechanisms underpinning the onset and progression of fibrosis in CKD and inhibiting those pathways is key to realizing novel treatments that meaningfully impact disease outcomes."

"With MTX-439 in the clinic, we are proud to be advancing three novel programs targeting fibrosis in SSc, IPF and now CKD fibrosis. Each program reflects the strength of our scientific approach and our commitment to developing therapies that address the underlying drivers of fibrosis rather than its symptoms," said Rahul Ballal, PhD, Chief Executive Officer, Mediar Therapeutics. "The expansion of our clinical advisory board with renowned kidney disease experts enables us to advance MTX-439 into later stage development with important rigor and a patient-centric focus."

In addition to MTX-439, Mediar is advancing two other novel anti-fibrotics in global Phase 2a studies: MTX-474, an anti-EphrinB2 antibody in development for SSc and MTX-463, a WISP1-targeting antibody in development for IPF under a global partnership with Eli Lilly and Company. The company continues to also build its R&D pipeline with bi-specific programs that pair its novel anti-fibrotics with validated targets in various disease areas.

About MTX-439
MTX-439 is a first-in-class human IgG1 antibody developed to neutralize the activity of SMOC2, a secreted matricellular protein implicated in the pathogenesis and progression of kidney fibrosis. SMOC2's expression correlates with disease severity in CKD and is measurable in patient samples, supporting its utility as both a therapeutic target and a precision biomarker. Preclinical studies have demonstrated that MTX-439 can disrupt profibrotic SMOC2-mediated signaling and significantly reduce fibrosis in human disease models. The current Phase 1 trial (NCT07473323) encompasses both healthy participants and adults with diabetic kidney disease, with plans to progress to a randomized Phase 2 program with clinical endpoints.

About MTX-474
MTX-474 is a first-in-class human IgG1 antibody designed to neutralize the EphrinB2 signaling that causes the onset and progression of fibrosis. Ephrin ligands and Eph receptors mediate biological processes involved in tissue fibrosis including cell migration, myofibroblast activation, and tissue remodeling. A growing body of evidence has implicated EphrinB2 in the fibrosis of the skin, lungs, and heart. Expression of EphrinB2 and its receptors is measurable in human blood and correlates with disease severity. A Phase 1 study was recently completed and a Phase 2 clinical study in patients with systemic sclerosis is now open (NCT07287670). More information can be found at www.encompassctrial.com.

About MTX-463
MTX-463 is a first-in-class human IgG1 antibody developed against WNT1-inducible signaling pathway protein-1 (WISP1). WISP1 is a secreted matricellular protein shown to have a relevant role in fibrosis progression, is measurable in human blood, and correlates with disease severity. Data indicates that MTX-463 neutralizes WISP1-mediated fibrotic signaling and significantly reduces fibrosis in vitro and in various preclinical models. A Phase 2 study in patients with idiopathic pulmonary fibrosis is now recruiting (NCT06967805). More information can be found at www.wispertrial.com.

About Mediar Therapeutics
Mediar Therapeutics is pioneering a new approach to fibrosis treatment that halts the disease at a different source – the myofibroblast, the key pathogenic cell in fibrosis that drives scarring, disease progression, and ultimately organ failure. Mediar was founded based on a deep understanding of the complex science underlying fibrosis onset and progression. By combining novel targets with reliable, easily detectable blood biomarkers and familiar modalities, Mediar is derisking the path forward for fibrosis therapies in clinical development. For more information, contact [email protected] or follow us on LinkedIn.

Mediar Therapeutics
Email: [email protected]

SOURCE Mediar Therapeutics